1. Field of the Invention
The present invention relates broadly to the problem of female urinary incontinence. More specifically, the invention relates to pubovaginal supports and methods for treating female urinary incontinence.
2. Description of the Related Art
Over 13 million people in the United States experience urinary incontinence. Urinary incontinence is the inability to control the emptying of the urinary bladder. During urination, muscles in the wall of the bladder contract, forcing urine out of the bladder and into the urethra. At the same time, sphincter muscles surrounding the urethra relax, letting urine pass out of the body. Incontinence will occur if bladder muscles suddenly contract or muscles surrounding the urethra are inadequate.
Stress incontinence is a type of urinary incontinence involving involuntary leakage of urine associated with effort, e.g. coughing, laughing, or sneezing. Stress incontinence is often due to weakness of the pelvic floor and bladder outlet. Pelvic floor muscles support your bladder. If these muscles weaken, the bladder drops, pushing slightly out of the bottom of the pelvis toward the vagina. This prevents muscles that ordinarily force the urethra shut from squeezing as tightly as they should. As a result, urine can leak into the urethra during moments of physical stress. Stress incontinence also may occur if the muscles that do the squeezing weaken. Women experience incontinence twice as often as men. Stress incontinence in particular is often caused by the physical changes resulting from pregnancy, childbirth, and menopause. It is the most common form of incontinence in women.
Stress incontinence can be treated by surgical procedures. One method of treating stress incontinence requires surgery to raise the bladder to a more normal position. Working through an incision in the vagina or abdomen, the surgeon raises the bladder and secures it with a string attached to muscle, ligament, or bone. In severe cases of stress incontinence, the surgeon may secure the bladder with a wide sling. This not only holds up the bladder but also compresses the bottom of the bladder and the top of the urethra, further preventing leakage. Slings may further allow for at least partial wrapping of the area to prevent the urethra from opening involuntarily.
Stress incontinence also may be treated by inserting a pubovaginal sling into the pelvis. Pubovaginal slings are physical structures used to support the bladder. Pubovaginal sling implant surgery is performed approximately 100,000 times per year in the United States alone. Current slings require abdominal incisions and use anchors, e.g., staples to implant the sling. Current slings further require anchoring the sling to the patient's pubic bone and/or abdomen, thus requiring multiple incisions, stitching, and the like, throughout the patient's pelvic region. To perform this type of surgery, general or spinal anesthesia often is given to the patient. Further, recovery is prolonged, and the patient's ambulatory functions are reduced during the significant healing time.
Generally, prior devices rely on tension to keep the pubovaginal sling in place. U.S. Pat. No. 6,039,686, issued to Kovac, (the '686 patent) describes a system and method for the long-term treatment of recurrent urinary female incontinence. As illustrated in FIG. 9 of the '686 patent, a sling 29 is anchored using screws 27, 28 in the pubic bone 1a, 1b, and is surgically implanted under the urethra 4. FIG. 10 of the '686 patent illustrates the sling 29 in position and anchored to the pelvis 1.
U.S. Pat. No. 5,647,836, issued to Blake, III et al., (the '836 patent) describes a system and method for treating female urinary incontinence. Anchoring devices or stays 24a,b, are implanted through the vaginal wall 10 and into the muscle or subcutaneous tissue 20, on two opposite sides of the urethra 12. The stays 24a, b, are connected to similar stays 26a, 26b, by sutures 28a, 28b. When drawn tight, the sutures compress the tissues around the urethra.
The pubovaginal sling described in U.S. Pat. No. 5,934,283, issued to Willem et al, (the '283 patent) includes limbs 24, 26, which are surgically implanted in the patient around the abdominal rectus sheath 70.
Although these devices generally functioned well and provided advantages over prior devices, the devices did not provide users with a minimally invasive device implantable without anchors, sutures, and the like. Known devices do not provide a device which can be implanted without typically administering general or spinal anesthesia. Known devices do not provide an implant which does rely on an anchoring mechanism to other bodily structures. Additionally, known devices do not provide a short recovery time.